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    Quality & RiskQuality SystemGlobal MarketsQSR / 21 CFR 820

    Quality System Regulation

    FDA's current good manufacturing practice (cGMP) requirements for medical devices.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    The Quality System Regulation (21 CFR Part 820) sets out the cGMP requirements that govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices intended for human use.
    What the regulation says
    The FDA's Quality System Regulation (21 CFR Part 820) establishes current good manufacturing practice (cGMP) requirements for medical devices, ensuring devices are safe and effective. It details requirements for quality system elements such as management responsibility, design control, purchasing, production and process controls, and corrective and preventive actions. Although the QSR is being replaced by the Quality Management System Regulation (QMSR) which harmonizes with ISO 13485:2016, its principles remain foundational for device quality.

    What this means in practice

    FDA has harmonized the QSR with ISO 13485:2016 in the Quality Management System Regulation (QMSR), which becomes effective in 2026. Manufacturers must align procedures with the new framework.

    Examples

    • A medical device manufacturer implements a robust design control process, as required by 21 CFR 820.30, ensuring that device requirements are defined, reviewed, and validated before production.
    • During an FDA inspection, a company demonstrates its adherence to 21 CFR 820.70 by providing records of equipment calibration and maintenance for manufacturing machinery.
    • A MedTech company establishes a corrective and preventive action (CAPA) system, in line with 21 CFR 820.100, to address nonconformities and prevent their recurrence.
    Common pitfalls
    • •Misinterpreting "harmonization" to mean identical, as there will still be FDA-specific requirements in the QMSR beyond ISO 13485:2016.
    • •Failing to adequately document design control activities, leading to challenges during FDA inspections.
    • •Assuming that compliance with ISO 13485:2016 automatically means full compliance with 21 CFR Part 820 without addressing FDA-specific nuances. Quality System Regulation (21 CFR Part 820) compliance is mandatory for medical devices marketed in the United States, while ISO 13485:2016 is a globally recognized voluntary standard that often satisfies QSR requirements.
    • •Neglecting to update quality system procedures and training to reflect the specific requirements of the Quality System Regulation (21 CFR Part 820) when operating in the US market, even if compliant with other international standards.
    • •Underestimating the importance of robust complaint handling and medical device reporting (MDR) as outlined in 21 CFR Part 820 Subpart M, which are critical for post-market surveillance.

    Frequently asked questions

    The primary purpose is to ensure that medical devices are safe and effective for human use by requiring manufacturers to follow current good manufacturing practices.

    Cross-references

    Governs

    Things this term applies rules or requirements to.

    Contains

    Sub-elements or required artefacts of this term.

    Replaced by

    Has been superseded by a newer term.

    Overlaps with

    Covers some of the same ground; not interchangeable.

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    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    eCFR·1FDA·1ISO·1
    1. 1
      Quality System Regulation (21 CFR 820)
      Verified
      eCFRecfr.gov
    2. 2
      FDA - Quality Systems
      Verified
      FDAfda.gov
    3. 3
      ISO 13485 Standard Page
      Verified
      ISOiso.org

    Inline markers like [1] jump to the matching reference above.